Piper Sandler upgrades Capricor stock rating on FDA review progress

Piper Sandler upgraded its rating on Capricor Therapeutics (NASDAQ:CAPR) stock to Overweight on Monday, increasing the price target to $25 from $2. The firm's decision was based on the FDA's extension of the Pre-Submission Review Date for the drug deramiocel, now set for November 22. This extension came after the Center for Biologics Evaluation and Research (CBER) accepted a significant amendment to the Biologics License Application (BLA).

The amendment included 24-month HOPE-3 OLE data and a more refined indication of upper limb function, specifically for Duchenne muscular dystrophy patients. Data published in The Lancet indicated that deramiocel resulted in an absolute decrease of 1.2 points less in PUL2.0 compared to placebo after 12 months. This represented a 4.55% difference or approximately a 54% slowdown in the loss of upper limb function.

While the FDA's acceptance of the major amendment and extension of the PDUFA date is a standard process, it does not guarantee approval of deramiocel. Piper Sandler noted that the stock had rallied 58% since the FDA announcement, currently trading at $9.91. Over the past week, CAPR shares posted a 19.5% gain, although the stock remains down 65% year-to-date.

As of the second quarter of 2026, Capricor ended the quarter with $238 million in cash, which far exceeded its debt on the balance sheet, resulting in a strong current ratio of 7.35.

InvestingPro analysis suggests that the stock is currently undervalued relative to its Fair Value, positioning the company as a potentially attractive investment opportunity. For more in-depth insights into CAPR's financial health and to access exclusive Pro Research Reports covering over 1,400 US stocks, readers are directed to InvestingPro.

Recent news highlights Capricor Therapeutics' ongoing developments, including the FDA's extension of the review period for deramiocel following the submission of a major amendment. This amendment incorporated additional HOPE-3 study data focusing on upper limb function for Duchenne muscular dystrophy patients.

The regulatory progress has attracted the attention of several analysts, with Oppenheimer upgrading the stock from Perform to Outperform and setting a price target of $54. Cantor Fitzgerald also upgraded Capricor's stock rating to Overweight from Neutral, raising the price target to $28. These upgrades reflect the company's recent regulatory updates and the advisory committee's mixed vote on the treatment.

The FDA's acceptance of the amendment underscores the significant unmet medical need in the treatment of Duchenne muscular dystrophy.